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Clinical Trials/NCT02113189
NCT02113189
Terminated
Not Applicable

The Long Term Impact of Walking Practice on Functional Mobility and Quality of Life in Persons With Parkinson's Disease

University of Texas Southwestern Medical Center1 site in 1 country13 target enrollmentApril 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson's Disease
Sponsor
University of Texas Southwestern Medical Center
Enrollment
13
Locations
1
Primary Endpoint
Change in Distance Walked on 6-Minute Walk Test (6MWT)
Status
Terminated
Last Updated
7 years ago

Overview

Brief Summary

The purpose of this study is to investigate the impact of a specifically designed leg brace on walking endurance in individuals with Parkinson's disease.

Detailed Description

This is a randomized, repeated measures, matched group study. There will be three groups of participants, 20 participants per group, 60 participants total. Group one (G1) will receive custom-fabricated bilateral braces and a standardized home walking/exercise program. Group two (G2) will receive an off-the shelf ankle support and standardized home walking/exercise program. Group three (G3) will receive the standardized walking/exercise program without any brace or AFO. Subjects will be randomized upon enrollment in the study. Subjects will be followed for one year during this study and outcome measures will be collected 3 times over the course of the study. Subjects will be seen every 6 months for the duration of the study for testing as well as for other visits as noted in the table below.

Registry
clinicaltrials.gov
Start Date
April 2014
End Date
October 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Karen McCain

Associate Professor

University of Texas Southwestern Medical Center

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of Parkinson's Disease according to the UK brain bank criteria.5
  • Age between 30 and
  • Ability to walk 150 feet independently over level surfaces with or without an assistive device.
  • Hoehn and Yahr stage 1-
  • Less than 10 full heel raises in single limb stance bilaterally.
  • Adequate insurance/funding to pay for physical therapy evaluation and AFO devices.

Exclusion Criteria

  • Body mass index greater than
  • Passive dorsiflexion range of motion less than approximately neutral (90 degrees)
  • Any other uncontrolled health condition for which gait training is contraindicated

Outcomes

Primary Outcomes

Change in Distance Walked on 6-Minute Walk Test (6MWT)

Time Frame: 6MWT will be done at initial testing and 12 months

Each participant walks at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices if necessary.

Secondary Outcomes

  • Change in Temporal Spatial Gait Parameters Using the Computerized Gait Analysis System(Testing will be done at initial testing and 12 months)

Study Sites (1)

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